Fight brewing over pregnancy-prevention device

Published 9:11 am, Wednesday, July 15, 2015

Cecilia Porras, from left, Elvira Lopez, Jordan Leininger and Kristen Jones stand in front of the Midland federal courthouse Wednesday to protest against the Essure IUD.

Cecilia Porras, from left, Elvira Lopez, Jordan Leininger and Kristen Jones stand in front of the Midland federal courthouse Wednesday to protest against the Essure IUD.

Fight brewing over pregnancy-prevention device

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A worldwide debate over a pregnancy-prevention device called Essure came to the Permian Basin Wednesday when four women protested in front of the federal courthouse building in Midland.

The device, which is made by the Bayer pharmaceutical company, is being blamed by the women for severe side effects despite their doctors’ assurances that the product was safe and proven.

“I have three kids and after my third kid I really wanted a tubal (ligation). I wanted to go in for surgery and come out,” said Kristen Jones, the local administrator for the Essure Problems Facebook group. “But my doctor said that this was a new procedure, that he had done hundreds of them, that it was safe.”

Jones had Essure — a nickel coil insert that implants into the fallopian tube — placed two years ago when she was 26. She claims that her adverse side effects began soon after the non-surgical procedure.

“About three days after is when my symptoms started with the bloating, abdominal pain, hair loss. I get dizziness, joint pains,” she said. “I’ve gained weight, and I’ve lost weight. I’ve gotten to a point lately where I don’t have an appetite anymore.”

The women, who range in age from 23 to 42, all blamed Essure for their problems. The Facebook page Essure Problems has more than 19,000 members and groups have been set up as far away as Europe.

Dr. Edio Zampaglione, vice president of medical affairs for women’s health at Bayer, said Wednesday in a phone interview that the device had undergone significant testing and that it had been used in more than 750,000 women. He said that the testing had shown that some of the side effects described by the women were considered normal.

“These are known adverse events from the clinical trials and from the procedure itself,” he said. “All our materials, the product labels … clearly states these potential adverse events and gives the percentage of the occurrence of them from the clinical trials.”

Zampaglione said that the number of complaints, which the FDA estimated to be around 5,000, is a small fraction of the overall number of women who have the device.

“When you look at the totality of all the data that’s out there … they are within what was expected looking from the clinical trials and what’s expected from this type of procedure and getting your tubes tied,” he said.

Deborah Kotz, press officer for Center for Devices and Radiological Health at the FDA, said that Essure has undergone multiple rounds of testing including a five-year study that gathered information on the effectiveness, safety and comfort of Essure after it was implanted. The FDA will be holding a public meeting of the Obstetrics and Gynecology Devices Panel on Sept. 24 to hear testimony and recommendations on how to move forward with Essure.

“At this meeting, the panel will be asked to evaluate currently available scientific data pertaining to the safety and effectiveness of the Essure System, including events related to implant perforation/migration, device removal, chronic pain, allergic reactions, and unintended pregnancy,” Kotz said in an emailed statement.

The panel will be able to give recommendations for new clinical studies, changes in labeling and other risk-management advice.

For Jones, the cost of getting the Essure device will end up being a hysterectomy, or a removal of her uterus, by the end of the year. Elvira Lopez, 42, already had a hysterectomy. She said that the change for her after her uterus and Essure was removed was like night and day.

“Now it’s like I'm a kid again,” Lopez said. “I do. I’ve told a lot of people I feel like I’m a teenager again. I have the energy, the stamina, I don’t get tired.”